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Last Updated: December 27, 2024

Details for New Drug Application (NDA): 072621

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NDA 072621 describes ACETYLCYSTEINE, which is a drug marketed by Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience Speclts, Zydus Pharms, Alvogen, Am Regent, Hospira, and Roxane, and is included in twenty-three NDAs. It is available from fifteen suppliers. Additional details are available on the ACETYLCYSTEINE profile page.

The generic ingredient in ACETYLCYSTEINE is acetylcysteine. There are three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

Summary for 072621

Tradename:	ACETYLCYSTEINE
Applicant:	Roxane
Ingredient:	acetylcysteine
Patents:	0

Medical Subject Heading (MeSH) Categories for 072621

Antiviral Agents
Expectorants
Free Radical Scavengers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION, ORAL			Strength	10%
Approval Date:	Sep 30, 1992	TE:		RLD:	No

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